Chiesi establishes Boston unit to support treatments for rare lysosomal storage, hematological and ophthalmological disorders in the US.
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Protalix BioTherapeutics and Chiesi Global Rare Diseases announced final study results from the BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating PRX 102 (pegunigalsidase alfa) for the treatment of Fabry Disease.
Protalix BioTherapeutics and Chiesi Global Rare Diseases announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company's Biologics License Application (BLA) seeking accelerated approval of PRX 102 (pegunigalsidase alfa) for the proposed treatment of adult patients with Fabry disease.
Protalix BioTherapeutics announced positive topline results from its Phase III BRIDGE clinical trial of PRX 102 (pegunigalsidase alfa), the Company's plant cell-expressed recombinant, PEGylated, cross-linked alpha-galactosidase-A product candidate under development for the treatment of Fabry disease.